对杏丁注射液热原检查质量标准的修订研究

STUDY ON THE STANDARD OF TEST FOR PYROGEN OF XINGDING INJECTION

目的:对杏丁注射液质量标准热原检查项进行修订。方法:采用《中国药典》2000年版二部附录ⅪD“热原检查法”。结果:按人用量4.5倍剂量,用原药液及10％葡萄糖注射液稀释一倍后分别进行实验,3h内均有严重降温现象;按人用量3倍剂量,不管稀释与否,降温均得到明显改善;按人用量的2.25倍剂量,用10％葡萄糖注射液稀释一倍后实验,降温改善更明显。结论:建议将标准修订为,用10％葡萄糖注射液稀释一倍后,按家兔每1kg体重静脉缓慢注射3ml,应符合规定。

Objective: To revise the standard of test for pyrogen of xingding injection.Method: Test for pyrogen method of the Chinese pharmacopocia 2000 was used.Result:The temperature seriously decreased in three hours in dosage of 4.5 times of the human and the temperature decrease was improved significantly in dosage of 3 times of the human when crude drug and dilution were given respectively.The temperature decrease was improved much more in dosage of 2.25 times of the human.Conclusion:The standard should be resived to use per kg of the rabbits weight 3ml dilution having been diluted one time by 10％ glucose injection to inject vein slowly.